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Updated: Sep 27, 2025
Transvaginal Mesh Insertion in the Ovine Model
Published on: July 27, 2017
Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the
Kai Dallas1, Colby P Souders1, Ashley Caron1
1From the Urology, Cedars-Sinai Medical Center.
Objective:
The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited.
Methods:
All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury.
Results:
Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once.
Conclusions:
The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.
Insights
Reports to the Manufacturer and User Facility Device Experience (MAUDE) database concerning vaginal mesh show potential bias. Manufacturers and attorneys dominate reporting, and many reports are later modified, impacting device safety assessments.
Area of Science:
- Medical device safety surveillance
- Regulatory science
- Biomedical informatics
Background:
- The Manufacturer and User Facility Device Experience (MAUDE) database collects adverse event reports for medical devices.
- Vaginal mesh implants have been associated with significant patient complications.
- Assessing the completeness and potential bias in MAUDE reports is crucial for understanding device safety.
Purpose of the Study:
- To investigate potential reporting bias in the MAUDE database concerning synthetic transvaginal mesh devices.
- To analyze the types of reporters and the nature of complaints submitted to MAUDE.
- To determine the frequency of report modifications after initial submission.
Main Methods:
- A comprehensive review of 40,266 safety reports submitted to MAUDE for synthetic transvaginal mesh from 2000-2017.
- In-depth analysis of a random 2% sample (900 reports) to identify reporter type and complaint details.
- Examination of report modifications within four years of submission.
Main Results:
- Sling reports constituted 70.7% of all identified vaginal mesh reports.
- Manufacturers (46%) and attorneys (41%) were the primary reporters, with healthcare providers (10%) and patients (2%) submitting fewer reports.
- 18.6% of reviewed reports were modified at least once after their initial submission.
Conclusions:
- The MAUDE database, while valuable, may present a biased view of vaginal mesh safety due to dominant reporting by manufacturers and attorneys.
- The frequency of report modifications suggests potential data variability.
- MAUDE data should not be the sole basis for assessing device safety, as it lacks information on complication-free procedures.
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